Phase I Vorinostat + Sorafenib in Patients With Advanced Solid Tumors

Phase I Vorinostat + Sorafenib in Patients With Advanced Solid Tumors

Solid Tumors

Unknown

1

Start Date 03/15/2008

Age of Trial (yrs) 16.7

Gleevec-resistant

HDAC inhibitor + KIT/PDGFRA inhibitor

Block KIT + Unblock cell death genes + Destroy KIT

GIST not specified. GIST patient enrollment unknown.

07-0537

Univ. of Colorado, Merck, Bayer

See site contact info below

Oral

Official Title: A Phase I Safety and Tolerability Study of Vorinostat in Combination With Sorafenib in Patients With Advanced Solid Tumors, With Exploration of Two Tumor-Type Specific Expanded Cohorts at the Recommended Phase 2 Dose (Renal Cell Carcinoma and Non-Small Cell Lung Carcinoma)

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: Vorinostat and sorafenib

Part A - Sorafenib bid (or qd if necessary) daily, D1-21, from cycle 1 (21 day cycle), vorinostat once daily D1-14 or D1-21 (depending on cohort).

Parts B and C - Sorafenib bid (or qd if necessary) daily, D1-21, from cycle 1 (21 day cycle), vorinostat once daily D1-14 or D1-21 (depending on cohort).